UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029048 |
|---|---|
| Receipt number | R000033212 |
| Scientific Title | Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting |
| Date of disclosure of the study information | 2017/09/09 |
| Last modified on | 2019/10/19 21:49:00 |
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Basic information
Public title
Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting
Acronym
Reasons for withdrawal from mirabegron for OAB
Scientific Title
Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting
Scientific Title:Acronym
Reasons for withdrawal from mirabegron for OAB
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The persistence of treatment with mirabegron and the reasons for withdrawal from the treatment among treatment-naive Japanese female patients with overactive bladder were prospectively investigated for 3 years in the real-world clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The reasons for withdrawal from the treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Post-menopausal treatment-naive Japanese female patients who visited the hospital for the symptoms of OAB and were clinically diagnosed with OAB
Key exclusion criteria
Patients with premenopausal, urinary tract infection, large postvoid residual volume (more than 150 mL), a previous treatment history for OAB, and contraindications to use of mirabegron
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Tanaka |
Organization
Hokkaido Prefectural Esashi Hospital
Division name
Division of Urology
Zip code
043-0022
Address
484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan
TEL
0139-52-0036
rinoshiyokanata@me.com
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Tanaka |
Organization
Hokkaido Prefectural Esashi Hospital
Division name
Division of Urology
Zip code
043-0022
Address
484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan
TEL
0139-52-0036
Homepage URL
rinoshiyokanata@me.com
Sponsor or person
Institute
Hokkaido Prefectural Esashi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hokkaido Prefectural Esashi Hospital
Address
484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan
Tel
0139-52-0036
hofuku.esabyo2@pref.hokkaido.jg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients visited the hospital between October 2011 and July 2014
Management information
Registered date
| 2017 | Year | 09 | Month | 07 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033212
